Latest news with #Itovebi
Business Insider
02-06-2025
- Business
- Business Insider
Genentech announces final results from OS analysis of Phase III INAVO120 study
Genentech, a member of the Roche (RHHBY) Group, announced positive final results from the overall survival, OS, analysis of the Phase III INAVO120 study. These data showed Itovebi, in combination with palbociclib and fulvestrant, reduced the risk of death by more than 30% compared with palbociclib and fulvestrant alone. This represents a statistically significant and clinically meaningful improvement in overall survival for people with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, endocrine-resistant, locally advanced or metastatic breast cancer. The results are being presented in an oral session at the 2025 American Society of Clinical Oncology, ASCO, Annual Meeting and simultaneously published in the New England Journal of Medicine, NEJM. The Itovebi-based regimen demonstrated a meaningful OS benefit compared with palbociclib and fulvestrant alone. The median OS was 34.0 months for people in the Itovebi arm, compared with 27.0 months in the palbociclib and fulvestrant arm. The benefit seen in delaying cancer progression was maintained in the updated analysis, with the Itovebi-based regimen showing a consistent improvement in median progression free survival of 17.2 months versus 7.3 months in the comparator arm. Confident Investing Starts Here:
Yahoo
31-05-2025
- Business
- Yahoo
Roche Gets CHMP Nod for Itovebi Combo in the EU for Breast Cancer
Roche RHHBY announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Itovebi (inavolisib) therapy for breast cancer. A final decision from the European Commission is expected soon. The company is seeking approval for a combination regimen of Itovebi with Pfizer's PFE Ibrance (palbociclib) and AstraZeneca's AZN Faslodex (fulvestrant). The intended treatment population includes adult patients with PIK3CA-mutated, ER-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. PFE's Ibrance and AZN's Faslodex are both currently approved for breast cancer treatment. Please note that Roche's Itovebi, in combination with Pfizer's Ibrance and AstraZeneca's Faslodex, is currently approved for the same indication as above in several geographies, including the United States, with additional applications under review by other regulatory authorities worldwide. Year to date, shares of RHHBY have surged 13.7% against the industry's decline of 5.7%. Image Source: Zacks Investment Research The favorable CHMP opinion is supported by findings from Roche's phase III INAVO120 study, which demonstrated a 57% reduction in the risk of disease progression or death (progression-free survival) for patients receiving the Itovebi-based regimen compared with those treated with Pfizer's Ibrance and AstraZeneca's Faslodex alone in the first-line setting. This benefit was consistent across all pre-specified subgroups, including patients with more aggressive disease that had spread to three or more locations. Additionally, the regimen was well tolerated, with no new safety concerns identified. In January 2025, positive top-line results from the final overall survival (OS) analysis of the INAVO120 study were announced, confirming a statistically significant and clinically meaningful survival advantage with the Itovebi-based treatment. Although OS data were still maturing at the time of the primary analysis, a clear favorable trend had already emerged. Full OS results are expected to be presented during an oral session at the 2025 American Society of Clinical Oncology Annual Meeting. Per Roche, PIK3CA mutations, which occur in roughly 40% of HR-positive breast cancers, are associated with more aggressive disease and poorer survival outcomes. This highlights the critical need for early PIK3CA mutation testing before initiating first-line treatment, enabling timely access to effective PI3K-targeted therapies for patients with a less favorable prognosis. The Itovebi-based regimen could redefine the standard of care in this first-line setting, where current treatment options remain limited, pending approval. Apart from the INAVO120 study, Roche is simultaneously evaluating various other combinations of Itovebi in three late-stage studies for treating PIK3CA-mutated, locally advanced or metastatic breast cancer. RHHBY is also planning further clinical investigations in breast cancer and other tumor types, aiming to extend the potential benefits of this targeted therapy to a broader population of patients with PIK3CA mutations. Roche Holding AG price-consensus-chart | Roche Holding AG Quote Roche currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Bayer BAYRY, carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. In the past 60 days, estimates for Bayer's earnings per share have increased from $1.19 to $1.25 for 2025. During the same time, earnings per share have increased from $1.28 to $1.31 for 2026. Year to date, shares of Bayer have gained 43.4%. BAYRY's earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AstraZeneca PLC (AZN) : Free Stock Analysis Report Roche Holding AG (RHHBY) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
Globe and Mail
26-05-2025
- Business
- Globe and Mail
Roche Gets CHMP Nod for Itovebi Combo in the EU for Breast Cancer
Roche RHHBY announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Itovebi (inavolisib) therapy for breast cancer. A final decision from the European Commission is expected soon. The company is seeking approval for a combination regimen of Itovebi with Pfizer 's PFE Ibrance (palbociclib) and AstraZeneca 's AZN Faslodex (fulvestrant). The intended treatment population includes adult patients with PIK3CA - mutated, ER-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. PFE's Ibrance and AZN's Faslodex are both currently approved for breast cancer treatment. Please note that Roche's Itovebi, in combination with Pfizer's Ibrance and AstraZeneca's Faslodex, is currently approved for the same indication as above in several geographies, including the United States, with additional applications under review by other regulatory authorities worldwide. Year to date, shares of RHHBY have surged 13.7% against the industry 's decline of 5.7%. More on the Positive CHMP Opinion for RHHBY's Itovebi Therapy The favorable CHMP opinion is supported by findings from Roche's phase III INAVO120 study, which demonstrated a 57% reduction in the risk of disease progression or death (progression-free survival) for patients receiving the Itovebi-based regimen compared with those treated with Pfizer's Ibrance and AstraZeneca's Faslodex alone in the first-line setting. This benefit was consistent across all pre-specified subgroups, including patients with more aggressive disease that had spread to three or more locations. Additionally, the regimen was well tolerated, with no new safety concerns identified. In January 2025, positive top-line results from the final overall survival (OS) analysis of the INAVO120 study were announced, confirming a statistically significant and clinically meaningful survival advantage with the Itovebi-based treatment. Although OS data were still maturing at the time of the primary analysis, a clear favorable trend had already emerged. Full OS results are expected to be presented during an oral session at the 2025 American Society of Clinical Oncology Annual Meeting. Per Roche, PIK3CA mutations, which occur in roughly 40% of HR-positive breast cancers, are associated with more aggressive disease and poorer survival outcomes. This highlights the critical need for early PIK3CA mutation testing before initiating first-line treatment, enabling timely access to effective PI3K-targeted therapies for patients with a less favorable prognosis. The Itovebi-based regimen could redefine the standard of care in this first-line setting, where current treatment options remain limited, pending approval. Apart from the INAVO120 study, Roche is simultaneously evaluating various other combinations of Itovebi in three late-stage studies for treating PIK3CA-mutated, locally advanced or metastatic breast cancer. RHHBY is also planning further clinical investigations in breast cancer and other tumor types, aiming to extend the potential benefits of this targeted therapy to a broader population of patients with PIK3CA mutations. RHHBY's Zacks Rank & Stock to Consider Roche currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Bayer BAYRY, carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. In the past 60 days, estimates for Bayer's earnings per share have increased from $1.19 to $1.25 for 2025. During the same time, earnings per share have increased from $1.28 to $1.31 for 2026. Year to date, shares of Bayer have gained 43.4%. BAYRY's earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%. 7 Best Stocks for the Next 30 Days Just released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers "Most Likely for Early Price Pops." Since 1988, the full list has beaten the market more than 2X over with an average gain of +23.0% per year. So be sure to give these hand picked 7 your immediate attention. See them now >> Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AstraZeneca PLC (AZN): Free Stock Analysis Report Roche Holding AG (RHHBY): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY): Free Stock Analysis Report This article originally published on Zacks Investment Research (
Yahoo
23-05-2025
- Business
- Yahoo
ASCO25: Roche's Itovebi combo reduces risk of death in breast cancer by 33%
Roche's blockbuster vision for phosphoinositide 3-kinase (PI3K inhibitor) Itovebi (inavolisib) has been dealt a boost after the drug demonstrated further positive overall survival (OS) data in a common subtype of breast cancer. In combination with Pfizer's CDK4/6 inhibitor Ibrance (palbociclib) and anti-oestrogen drug Faslodex (fulvestrant), Itovebi reduced the risk of death by 33% in patients with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer that has grown during or after hormone therapy treatment. The new OS results came from the Phase III INAVO120 study (NCT05646862) evaluating the triple therapy compared to Ibrance and Faslodex alone. Roche published an abstract containing the data ahead of a presentation at the American Society of Clinical Oncology (ASCO) 2025 meeting taking place from 30 May to 3 June in Chicago, Illinois. Itovebi won US Food and Drug Administration (FDA) approval in this breast cancer indication based on INAVO120's data late last year, although full analysis of the OS has only been completed by Roche now. The study, which enrolled 325 patients, saw Roche's Itovebi combination led to a median OS of 34 months compared to 27 months for those who took a placebo along with Ibrance and Faslodex. The median follow-up was just under three years. The results consolidate previous data that showed adding Itovebi to the treatment regimen more than doubled progression-free survival (PFS) to 15 months. With the full analysis now available, Roche has updated this to 17.2 months, compared to the 7.3 months in the comparator arm. Coupled with the OS data, the results are a landmark moment in the P13KCA landscape. No other pharma company has developed a candidate that reaches the 33% Itovebi has achieved. For example, rival PI3K inhibitor Piqray developed by Novartis, failed to produce a statistically significant difference in OS in breast cancer patients with a PIK3CA mutation. Piqray is FDA-approved as a second-line therapy option, whereas Itovebi is a first-line treatment. HR-positive, HER2-negative breast cancer is the most common subtype of breast cancer. About 40% of these patients have a mutation in the PIK3CA gene. PI3K inhibitors have long been troubled by safety concerns. Roche's Itovebi is no different, with 90.7% of patients experiencing Grade 3 or 4 adverse events (AEs). However, a high rate was also seen in the placebo/Ibrance/Faslodex arm – 84.7%. Hyperglycaemia was an AE singled out in the analysis, being particularly prevalent in the Itovebi group at 63.4%, versus 13.5% in the other arm. Backed by previous survival data, Roche has high hopes for Itovebi, forecasting peak sales of $2.3bn. Analysis by GlobalData, which goes up to 2031, has forecast peak sales of $1.4bn. GlobalData is the parent company of Pharmaceutical Technology and Clinical Trials Arena. 'The INAVO120 trial has identified a targeted treatment regimen that meaningfully improves survival in patients with untreated PIK3CA-mutated hormone receptor-positive metastatic breast cancer – a big step forward for these patients,' said Jane Lowe Meisel, co-director of Breast Medical Oncology at the Winship Cancer Institute of Emory University School of Medicine, and an ASCO Expert in breast cancer. "This study illustrates the importance of genomic testing at the time of diagnosis of hormone receptor-positive metastatic breast cancer so that patients with PIK3CA mutations who qualify for this approach can be readily identified.' "ASCO25: Roche's Itovebi combo reduces risk of death in breast cancer by 33%" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
28-01-2025
- Health
- Yahoo
Genentech's Itovebi combo hits overall survival endpoint in HER2- breast cancer
Genentech Therapeutics's Phase III trial of Itovebi in patients with certain types of metastatic breast cancer has met the gold standard oncology endpoint of overall survival (OS) while also delaying disease progression. Further results from the randomised, double-blind trial (NCT04191499) showed that Itovebi, otherwise known as inavolisib, when used in combination with Ibrance (palbociclib) and Faslodex (fulvestrant) met its secondary endpoint by showing a statistical and clinically meaningful benefit in OS in patients living with PIK3CA-mutated, hormone receptor (HR) positive, human epidermal growth factor receptor 2 negative (HER2) negative breast cancers. This news comes three months after the US Food and Drug Administration (FDA) approved the Itovebi combination as a first-line therapy based on this Phase III trial. The combination therapy is approved for patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer. Primary analysis from the INAVO120 trial was published in December 2023 found the Itovebi combination regimen reduced the risk of disease worsening or death by 57% compared with Ibrance and Faslodex alone. At the time of the primary analysis, data on the secondary endpoint of OS was still immature. In the secondary analysis, the company added that no new safety signals have been discovered since publishing its primary analysis. Chief medical officer for the Roche subsidiary, Levi Garraway, said: 'These findings underscore our ambition to improve survival rates for people with breast cancer. The Itovebi-based regimen has the potential to become the new standard of care for these patients. 'The INAVO120 overall survival results show that the Itovebi-based regimen not only delayed disease progression, but also helped people with advanced HR-positive, PIK3CA-mutated breast cancer live longer.' The INAVO120 trial comes as part of a series of trials examining Itovebi with Ibrance and Faslodex against placebo across a number of HER2- and HR-positive cancers. Of the still ongoing trials, INAVO121 (NCT05646862) is examining the combination treatment following cyclin-dependent kinase 4/6 inhibitor and endocrine combination therapy. The INAVO122 trial (NCT05894239) examines the regimen in combination with HER2 blockade versus dual HER2 blockade. Meanwhile, the INAVO123 trial (NCT06790693) was in combination with CDK4/6i and letrozole. Now, the company has said that a full analysis of the secondary endpoint will be discussed at an upcoming meeting. Research by GlobalData estimates that Itovebi is estimated to earn approximately $164m in sales by the end of 2025, with the drug forecasted to reach blockbuster status, with sales set to rise to $1.3bn by the end of 2030. GlobalData is the parent company of Clinical Trials Arena. Elsewhere in the world of HER2-related cancers, MSD and Eisai have announced mixed results from a Phase III trial of a Keytruda (pembrolizumab) combination as a first-line treatment for patients with HER2 negative gastroesophageal adenocarcinoma. "Genentech's Itovebi combo hits overall survival endpoint in HER2- breast cancer" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
